Registration Dossier
Registration Dossier
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EC number: 207-997-3 | CAS number: 504-63-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- ACC PDO panel assigned reliability of 2. PDO from chemical process.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
- Principles of method if other than guideline:
- RANGEFINDING: Preliminary observations showed that one intradermal injection of 0.1 mL of a 25% aqueous dilution induced a moderate skin reaction.
MAIN STUDY INDUCTION EXPOSURE: 10 exposures, 8 animals, 3 times/week for 3 weeks
CHALLENGE EXPOSURE: 1 exposure, 8 animals plus 8 control animals received no induction injection but received the 0.05 mL of the 10% dilution along with the test animals during the challenge exposure. - GLP compliance:
- not specified
- Type of study:
- other: Landsteiner/Draize test
- Justification for non-LLNA method:
- Guinea pig data were available prior to implementaiton of REACH.
Test material
- Reference substance name:
- Propane-1,3-diol
- EC Number:
- 207-997-3
- EC Name:
- Propane-1,3-diol
- Cas Number:
- 504-63-2
- Molecular formula:
- C3H8O2
- IUPAC Name:
- propane-1,3-diol
- Details on test material:
- - Name of test material (as cited in study report): propanediol-1,3
- Purity: Not reported
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: albino SPF
- Sex:
- male
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- First injection of induction- 0.05 ml of 25% dilution
2nd to the 10th injection of induction- 0.01ml of 25% dilution
Challenge dose-0.05ml of 10% dilution
Challengeopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- First injection of induction- 0.05 ml of 25% dilution
2nd to the 10th injection of induction- 0.01ml of 25% dilution
Challenge dose-0.05ml of 10% dilution
- No. of animals per dose:
- 8/group
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- other: not reported
Any other information on results incl. tables
Animal Number |
Individual Direct Reaction |
Challenge |
Animal Number |
Control Reaction |
|||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
||||
2314 |
+ |
+ |
++ |
+ |
+ |
++ |
++ |
++ |
++ |
++ |
+ |
2325 |
+- |
2315 |
++ |
+ |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
|
2326 |
|
2316 |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
+ |
+ |
2327 |
+- |
2317 |
+ |
+ |
++ |
++ |
++ |
++ |
++ |
+++ |
+++ |
++ |
+ |
2328 |
+- |
2318 |
+ |
+ |
++ |
++ |
++ |
++ |
++ |
++ |
+++ |
++ |
+- |
2329 |
|
2319 |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
+- |
2330 |
+- |
2320 |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
++ |
+++ |
++ |
+- |
2331 |
+- |
2324 |
+ |
+ |
++ |
++ |
++ |
++ |
++ |
++ |
+++ |
+++ |
+ |
2332 |
+ |
+- = very mild; + = mild; ++ = moderate; +++ = severe
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Test samples caused mild to severe reactions upon repeated exposure during induction. Challenge exposure showed no significant difference between test and control animals. Authors conclude that "no sensitization occurred."
- Executive summary:
1,3-Propanediol was tested for possible sensitization properties in a Landsteiner/Draize test with guinea pigs. Test samples caused mild to severe reactions upon repeated exposure during induction. Challenge exposure showed no significant difference between test and control animals. Authors conclude that "no sensitization occurred."
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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